Sepsis
Conditions
Brief summary
Recent evidence suggests that sepsis continuum includes an immune paralytic state, which may play a significant role in sepsis. Mycobacterium w by its TLR4 agonist activity may help in restoring immunity, thereby improving outcomes in patients with severe sepsis. In this randomized trial, the investigators propose to evaluate the efficacy of Mw in patients with severe sepsis.
Interventions
BIOLOGICALMycobacterium w
Single daily dose of 0.3 mL of Mw (heat-inactivated Mw \[0.5 × 10\^9\]; Immuvac, Cadila Pharma, Ahmedabad, India) in the deltoid region for 3 consecutive days
OTHERBest standard care
Antibiotics as early as possible; Norepinephrine \> vasopressin \> epinephrine for hypotension; Blood glucose 140-180 mg/dL; DVT and stress ulcer prophylaxis; Low tidal volume mechanical ventilation; Standard VAP, CLABSI prevention bundles
Sponsors
Pandit Bhagwat Dayal Sharma, PGIMS, Rohtak
St.John's National Academy of Health Sciences
Post Graduate Institute of Medical Education and Research, Chandigarh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Patients with severe sepsis within 48 hours of first organ dysfunction * Cardiovascular system dysfunction: systolic blood pressure ≤90 mm Hg or the mean arterial pressure ≤70 mm Hg for at least one hour despite adequate fluid resuscitation or the use of vasopressors to maintain a systolic blood pressure or mean arterial pressure of \>90 and \>65 mm Hg, respectively * Renal dysfunction: urine output \<0.5 ml/kg/hour for two consecutive hours despite adequate fluid resuscitation * Respiratory system dysfunction: PaO2/FiO2 ≤300 or ≤250 if lung sepsis * Hematologic dysfunction: platelet count \<100,000/mm3 or decrease by 50% in the three days preceding enrollment * Unexplained metabolic acidosis: pH ≤7.30
Exclusion criteria
* Pregnancy * Gram-positive culture * Only fungal infection as source of sepsis * Patients who received cardiopulmonary resuscitation * Those on immunosuppressive therapy * Those unwilling to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 28-day | 28-day all-cause mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ventilator-free days | 28-day | Day off the mechanical ventilator |
| Time-to-vasopressor withdrawal | 28-day | — |
| New onset organ dysfunction measured by delta SOFA (maximum minus baseline SOFA) | 28-day | Measured by delta SOFA (maximum minus baseline SOFA) |
| Hospital length of stay | 28-day | — |
| New-onset infection | 28-day | — |
| ICU length of stay | 28-day | — |
Countries
India
Outcome results
None listed